510(k) K123557
- Device
- EASYCARE ONLINE
- Applicant
- RESMED LTD.
- 510(k) number
- K123557
- Product code
- MNS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-14
- Date received
- 2012-11-19
- Regulation
- 868.5895
- Classification name
- Ventilator, Continuous, Non-life-supporting
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JIM CASSI
- Address
- 9001 Spectrum Center Blvd. San Diego CA US 92123 92123
FDA Registration Numbers#
- 3004604967
- 3012305175
- 3033526676
- 3023272766
- 3004748541
- 3017684630
- 3011120183
- 3001400310
- 3004802249
- 3010817335
- 3013154126
- 3029227324
- 3033530343
- 2518422
- 3012428212
- 3007421149
- 3002797442
- 3007220521
- 3008566132
- 3013075752
- 3011205710
- 3013505405
- 3038562397
- 3007573469
- 8040510
- 3026086583
- 3009096682
- 9617566
- 3023322457
- 3018783526
- 9680721
- 3000126629
Source Documents#
Other 510(k) Records For Product Code MNS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251889 | myAir | Resmed Corp | 2026-04-08 |
| K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | 2026-03-17 |
| K251661 | Mariana Minerva; Mariana Nimbus | Resmed Pty , Ltd. | 2026-02-23 |
| K240778 | Vivo 1, Vivo 2 | Breas Medical AB | 2024-12-13 |
| K231064 | ReddyPort Elbow | Smd Manufacturing, LLC | 2023-07-13 |
| K213169 | BPAP System | BMC Medical Co., Ltd. | 2022-12-05 |
| K171827 | ReddyPort NIV Access Elbow | Smd Manufacturing, LLC | 2018-01-19 |
| K161492 | Juno VPAP ST-A | Resmed, Ltd. | 2017-01-19 |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Resmed, Ltd. | 2016-09-09 |
| K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016-04-13 |
| K132371 | EASYCARE ONLINE | Resmed, Ltd. | 2013-11-22 |
| K123511 | S9 VPAP TX | Resmed, Ltd. | 2013-03-21 |
| K122324 | VPAP S-A | Resmed, Ltd. | 2012-11-13 |
| K113714 | VPAP TX | Resmed, Ltd. | 2012-05-25 |
| K113288 | VPAP ST-A | Resmed, Ltd. | 2012-03-29 |
Legacy Summary#
summary
FDA Review#
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